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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

NCT03841773 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2025-02-06

Study results available
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Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

Conditions

Interventions

DRUG

TNX-102 SL

Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks

DRUG

Placebo SL Tablets

Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory M Sullivan, MD · Tonix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2020-04-24
Completion
2020-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841773 on ClinicalTrials.gov